Glaxosmithkline Biologicals Sa v Comptroller-general of Patents, Designs and Trade Marks
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 21 March 2013 |
| Neutral Citation | [2013] EWHC 619 (Pat) |
| Docket Number | Case No: CH/2013/0043 |
| Court | Chancery Division (Patents Court) |
| Date | 21 March 2013 |
[2013] EWHC 619 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case No: CH/2013/0043
Daniel Alexander QC (instructed by Simmons and Simmons) for the Appellant
Charlotte May (instructed by the Treasury Solicitor) for the Respondent
Hearing date: 8 March 2013
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Contents
| Topic | Paragraphs |
| Introduction | 1-4 |
| The SPC Regulation | 5-6 |
| Technical background | 7-32 |
| Immunity | 8-15 |
| Vaccination | 16-18 |
| Influenza vaccines | 19-23 |
| Vaccine antigens | 24-26 |
| Adjuvants | 27-32 |
| AS03 | 33-36 |
| Prepandrix | 37 |
| Earlier case law | 38-56 |
| Pharmacia | 39-41 |
| MIT | 42-47 |
| Yissum | 48-51 |
| Neurim | 52-56 |
| Bayer CropScience | 57-66 |
| The issue in the present case | 67-81 |
| Conclusion | 82-86 |
Introduction
On 10 October 2008 the Appellant ("GSK") filed application SPC/GB08/046 for a supplementary protection certificate for "an oil in water emulsion comprising squalene, DL-a-tocopherol and polysorbate 80", an adjuvant known as AS03 which is protected by European Patent (UK) No 0 868 918.
On 18 August 2011 GSK filed application SPC/GB11/043 for a supplementary protection certificate for "an adjuvanted influenza vaccine comprising an influenza virus component which is an influenza virus antigen from an influenza virus strain that is associated with a pandemic outbreak or has the potential to be associated with a pandemic outbreak, wherein the adjuvant is an oil in water emulsion comprising squalene, DL-a-tocopherol and polysorbate 80", a vaccine comprising an antigen and AS03 which is protected by European Patent (UK) No 1 618 889.
In both applications GSK relied upon marketing authorisation EU/1/08/453/001 for a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A virus marketed by GSK under the trade mark Prepandrix.
By a decision dated 19 December 2012 ( BL O/506/12), Dr C.L. Davies, the Deputy Director of the UK Intellectual Property Office, acting on behalf of the Comptroller, decided that neither application was allowable as it stood since AS03 was not an "active ingredient" of Prepandrix, although she was prepared to give GSK an opportunity to amend the applications. GSK has appealed against this decision. It is common ground that the resolution of the appeal depends on an issue of interpretation of Article 1(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the SPC Regulation") upon which a preliminary ruling from the Court of Justice of the European Union is required.
The SPC Regulation
The SPC Regulation includes the following recitals:
"(3) Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.
(4) At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
(5) This situation leads to a lack of protection which penalises pharmaceutical research.
(6) There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.
(7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.
(8) Therefore, the creation of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument.
(9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.
(10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product."
Articles 1, 2 and 3 of the SPC Regulation provide:
"Article 1
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a) 'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) 'product' means the active ingredient or combination of active ingredients of a medicinal product;
(c) 'basic patent' means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
…
Article 2
Scope
Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.
Article 3
Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product."
Technical background
The following account is based upon evidence given by Professor Geert Leroux-Roels in an expert report submitted by GSK prior to the hearing before the Deputy Director and upon scientific literature which he exhibited to that report. Professor Leroux-Roels is an experienced and distinguished scientist in the field of immunology. Having held a number of positions at Ghent University between 1983 and 1995, he has been Director of CEVAC — The Centre for Vaccinology — Ghent University Hospital since 1995. He is an author of over 250 publications in the field. His evidence was not tested in cross-examination, but there is no reason to think that it is not technically accurate. Any inaccuracies in the following summary will be attributable to me.
Immunity
Immunity is the general term used to describe the body's ability to resist infection by a particular pathogen (a microorganism that typically causes a disease upon infection or in the context of failing immunity). There are, broadly speaking, two main types of immunity: innate immunity and adaptive immunity.
Innate immunity describes the various resistance mechanisms that are first encountered by a pathogen upon infection. These are general and non-specific responses which are present in all individuals at all times and are not affected (nor enhanced) by repeated exposure to a particular pathogen. Aspects of the innate immune response include, for example, anatomical barriers to infection, the "complement system" (the coating of a pathogen by proteins which facilitates its removal by phagocytes, which engulf the coated pathogen) and the responses that are triggered by recognition of a pathogen-associated molecular pattern (PAMP). PAMPs are molecules that are specifically associated with groups of pathogens. They are recognised by receptors, such as Toll-like receptors (TLRs), expressed extra-or intracellularly in antigen-presenting cells (APCs) of the innate immune system. APCs are cells (such as dendritic cells, monocytes and macrophages) that display foreign antigen complexes with major histocompatibility complex (MHC) on their surface. Recognition of PAMPs by TLRs triggers signals, including the secretion of cytokines, which help initiate immune responses.
Adaptive immunity occurs after the innate...
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